Actively Recruiting
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Led by Kai Hu · Updated on 2025-02-12
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This is an early-phase, single-arm, open-label clinical study enrolling between 6 and 24 participants to explore how these specialized immune cells behave and impact the disease. Participants will receive an infusion of CT1190B CAR-T cells as the experimental treatment. The study focuses on assessing the dose range and safety within 28 days after infusion. It includes monitoring overall response and remission rates at 4 weeks, 8 weeks, 12 weeks, and then at 6, 9, and 12 months post-infusion. During the study, participants will undergo regular evaluations including safety assessments for adverse events up to 12 months after infusion. Researchers will monitor response times, duration of remission, progression-free survival, and overall survival over one year. Long-term follow-up is planned for up to 15 years to gather extended safety and efficacy data. Participants will be closely observed through scheduled visits and tests throughout the study period.
CONDITIONS
Brief Title
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign the informed consent form and agree to adhere to study visits and protocol requirements, including long-term follow-up for up to 15 years
- Age between 18 and 75 years
- Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma
- Previously received at least two lines of systemic therapy
- Intolerance to last treatment, or disease progression on or after last treatment requiring therapy
- Presence of measurable target lesions
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test before treatment and agree to use effective contraception for 1 year after treatment; male participants must also use effective contraception if sexually active with female partners of childbearing potential
- Participants must not donate eggs or sperm for 1 year after receiving study treatment infusion
You will not qualify if you...
- Pregnant or breastfeeding women
- Infection with HIV, syphilis, active hepatitis B or C virus
- Current uncontrolled active infections including active tuberculosis
- Toxicities from previous treatments not resolved to mild or better (grade 1 or less), except alopecia or other tolerable events
- Treatment for the disease within 14 days before informed consent, including cytotoxic therapy, monoclonal antibodies, targeted therapy, radiotherapy, epigenetic therapy, investigational agents, or invasive devices
- Use of systemic glucocorticoids equivalent to more than 15 mg/day prednisone within 7 days prior to consent, except topical glucocorticoids
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks prior to consent
- Allergy or intolerance to preconditioning drugs, tocilizumab, or history of severe allergy such as anaphylaxis
- Any heart disease within 6 months prior to screening
- Oxygen saturation below 92%
- Presence of a second primary cancer requiring treatment or not in remission within 2 years
- Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment, excluding minor local anesthesia procedures
- Inability or unwillingness to comply with study protocol or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after CAR-T cells infusion
Participants receive CT1190B CAR-T cell infusion as the study treatment.
1 infusion visit and multiple follow-up visits over 28 days
Duration - Up to 12 months after CT1190B infusion
Participants are monitored for safety, efficacy, and long-term outcomes after treatment.
Visits at 4, 8, 12 weeks and 6, 9, 12 months after infusion
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
Research Team
K
Kai Hu MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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